Orange Book product · Brand (NDA)
ANAPROX
NAPROXEN SODIUM
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
NAPROXEN SODIUM
Strength
EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 018164
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2006NAPROXEN SODIUMBrand (NDA)
NDA 021920 · BIONPHARMA
- 1996NAPRELANBrand (NDA)
NDA 020353 · TWI PHARMS
- 1994ALEVEBrand (NDA)
NDA 020204 · BAYER
- 2023NAPROXEN SODIUMGeneric (ANDA)
ANDA 214463 · PATHEON SOFTGELS
- 2022NAPROXEN SODIUMGeneric (ANDA)
ANDA 211065 · HETERO LABS LTD V
- 2022NAPROXEN SODIUMGeneric (ANDA)
ANDA 215472 · ONESOURCE SPECIALTY
- 2019NAPROXEN SODIUMGeneric (ANDA)
ANDA 212199 · SCIEGEN PHARMS
- 2019NAPROXEN SODIUMGeneric (ANDA)
ANDA 212033 · YICHANG HUMANWELL
- 2019NAPROXEN SODIUMGeneric (ANDA)
ANDA 202807 · CATALENT
- 2018NAPROXEN SODIUMGeneric (ANDA)
ANDA 207612 · NOVELGENIX THERAPS
- 2018NAPROXEN SODIUMGeneric (ANDA)
ANDA 208363 · PURACAP PHARM LLC
- 2017NAPROXEN SODIUMGeneric (ANDA)
ANDA 204872 · LNK INTL INC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
